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business development and application scientist

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process development scientist

US Pharmacopeia

<div>
 
 Description
 
 
 
 
 Who is USP?
 
 
 
 The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
 
 
 At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.
 
 
 USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work&mdash;an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
 
 
 
 Brief Job Overview
 
 
 
 The role is engaged in the synthesis and delivery of USP Reference Standard candidate materials and API impurities through design and development of cost-effective synthetic routes. Candidate should carry literature search using scientific databases and work on planning and execution of synthesis of target molecules in mg to multigram/KG scale. Candidate should ensure the completion of assigned tasks as per timelines, prepare project reports, communicate with the team and update on the project progress. Candidate should be adherent to quality management systems (QMS) and lab safety practices.
 
 
 
 How will YOU create impact here at USP?
 
 
 
 In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.
 
 
 
 The Scientist III Has The Following Responsibilities
 
 
 
 <ul>
 <li>
 Carry out literature search related to assigned projects using various scientific data bases.
 </li>
 <li>
 Design synthetic routes for the target molecules and prepare project proposals with tentative cost estimates
 </li>
 <li>
 Procure key raw materials and reagents required for the project
 </li>
 <li>
 Perform the reactions in small as well as large scale in the lab for the synthesis of target compounds
 </li>
 <li>
 Purification of compounds through various techniques such as crystallization, column chromatography, and advanced flash purification systems.
 </li>
 <li>
 Troubleshooting synthesis and purification issues
 </li>
 <li>
 Contributing effectively towards more challenging and complex projects through innovative methodologies
 </li>
 <li>
 Ensuring the availability of chemicals and equipment required for the projects and forward the purchase requisitions
 </li>
 <li>
 Interpretation of analytical data of synthesized compounds by IR, NMR, Mass Spectra, Elemental analysis etc.
 </li>
 <li>
 Produce quality materials as per customer requirement
 </li>
 <li>
 Packaging of synthesized compounds
 </li>
 <li>
 Plan, execute and complete the projects as per the timelines
 </li>
 <li>
 Document all experiments conducted as per QMS guidelines.
 </li>
 <li>
 Responsible to ensure the calibrations of the equipment as per the schedule
 </li>
 <li>
 Periodic check of the assigned equipment to ensure its working condition
 </li>
 <li>
 Work on any other assigned tasks/ lab management activities/ organizational initiatives
 </li>
 <li>
 Conversant with lab safety norms and strictly follow them.
 </li>
 <li>
 Communicate within the team and cross functional teams
 </li>
 <li>
 Learn and practice Diversity, Equity, Inclusion &amp; Belonging culture
 
 
 </li>
 </ul>
 
 Who is USP Looking For?
 
 
 
 The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
 
 
 <ul>
 <li>
 Scientist III &ndash; Ph.D. (Full Time) in Synthetic Organic Chemistry from a reputed group with minimum 1-3 years post-doctoral/ industrial experience in API Process R&amp;D/CDMO/CRO
 
 
 </li>
 </ul>
 (Or)
 
 
 <ul>
 <li>
 M Sc (Organic Chemistry) from a reputed university with minimum 6-8 years of industrial experience in API Process R&amp;D/CDMO/CRO
 </li>
 <li>
 Strong background in synthetic organic chemistry, Interpretation of spectral data of compounds based on IR, NMR, HPLC, Mass, Elemental analysis and other analysis.
 </li>
 <li>
 Ability to independently search literature, design, optimize and develop synthetic processes for any given target molecules/APIs.
 </li>
 <li>
 Hands on experience in process development of diverse chemical class of APIs/ NCEs on lab scale and production.
 </li>
 <li>
 Proven ability for adoption of QMS and documentation procedure.
 </li>
 <li>
 Adherence to lab safety guidelines.
 </li>
 <li>
 Excellent troubleshooting skills in synthesis and purification of target compounds.
 </li>
 <li>
 Should possess good verbal and written communication skills.
 </li>
 <li>
 Should possess good organizational, communication, and interpersonal skills.
 
 
 </li>
 </ul>
 
 Additional Desired Preferences
 
 
 
 <ul>
 <li>
 Extensive knowledge on wide range of organic reactions and hands on experience in handling various sensitive chemicals/reagents.
 </li>
 <li>
 Experience in flow chemistry applications in process development
 </li>
 <li>
 Track record of patents/ publications in synthetic organic chemistry/ process development.
 </li>
 <li>
 Should have exposure to GMP/GLP environment and documentation procedures.
 </li>
 <li>
 Good practical, documentation &amp; presentation skills.
 </li>
 <li>
 Attention to detail, stratregic thinking and problem-solving skills.
 </li>
 <li>
 Demonstrated ability to work both independently and as a member of a team with a passion for quality
 
 
 </li>
 </ul>
 
 Supervisory Responsibilities
 
 
 
 No
 
 
 
 Benefits
 
 
 
 USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
 
 
 Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
 
 
 
 Job Category
 
 Chemistry &amp; Scientific Standards
 
 
 
 Job Type
 
 Full-Time
</div>

Scientist III, Synthetics Laboratory

<div>
 
 Description
 
 
 
 
 Who is USP?
 
 
 
 The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world&rsquo;s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.
 
 
 At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.
 
 
 USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds&mdash;regardless of background&mdash;to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.
 
 
 
 Brief Job Overview
 
 
 
 This is a non-supervisory position engaged in the synthesis and delivery of USP Reference Standard candidate materials and API impurities through design and development of cost-effective synthetic routes. Should carry literature search using scientific databases and work on planning and execution of synthesis of target molecules in mg to multigram/KG scale. Should ensure the completion of assigned tasks as per timelines, prepare project reports, communicate with the team and update on the project progress. Should be adherent to quality management systems (QMS) and lab safety practices.
 
 
 
 How will YOU create impact here at USP?
 
 
 
 As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.
 
 
 Additionally, USP&rsquo;s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.
 
 
 The [Scientist III/IV] has the following responsibilities:
 
 
 <ul>
 <li>
 Carry out literature search related to assigned projects using various scientific data base.
 </li>
 <li>
 Design synthetic routes for the target small molecules. Prepare project proposals with tentative cost estimates.
 </li>
 <li>
 Perform synthesis &amp; isolation of pharmaceutical analytical impurities, reference standards and degradation impurity standards.
 </li>
 <li>
 Procure key raw materials and reagents required for the project
 </li>
 <li>
 Perform the reactions in small as well as large scale in the lab for the synthesis of target compounds
 </li>
 <li>
 Purification of compounds through various techniques such as crystallization, column chromatography, and advanced flash purification systems.
 </li>
 <li>
 Troubleshooting synthesis and purification issues independently
 </li>
 <li>
 Contributing effectively towards more challenging and complex projects through innovative methodologies
 </li>
 <li>
 Ensuring the availability of chemicals and equipment required for the projects and forward the purchase requisitions
 </li>
 <li>
 Interpretation of analytical data of synthesized compounds by IR, NMR, Mass Spectra, Elemental analysis etc.
 </li>
 <li>
 Produce quality materials as per customer requirement
 </li>
 <li>
 Packaging of synthesized compounds
 </li>
 <li>
 Plan, execute and complete the projects as per the timelines
 </li>
 <li>
 Document all experiments conducted as per QMS guidelines.
 </li>
 <li>
 Responsible for preparation of SOPs, Protocols, reports etc. as per the need
 </li>
 <li>
 Responsible for review the records and documents
 </li>
 <li>
 Responsible to ensure the calibrations of the equipment as per the schedule
 </li>
 <li>
 Periodic check of the assigned equipment to ensure its working condition
 </li>
 <li>
 Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments as assigned
 </li>
 <li>
 Work on any other assigned tasks/ lab management activities.
 </li>
 <li>
 Conversant with lab safety norms and strictly follow them.
 </li>
 <li>
 Communicate within the team and cross functional teams
 </li>
 <li>
 Learn and practice Diversity, Equity, Inclusion &amp; Belonging culture.
 
 
 </li>
 </ul>
 
 Who is USP Looking For?
 
 
 
 The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
 
 
 <ul>
 <li>
 Scientist III/IV &ndash; Ph.D (Full Time) in Synthetic Organic Chemistry from a reputed group with minimum 0-7 years post-doctoral/industrial research experience in organic synthesis.
 
 
 </li>
 </ul>
 (Or)
 
 
 M Sc (Organic Chemistry) from a reputed university with minimum 6-10 years of industrial experience in Pharmaceutical Process R&amp;D or CRAMS or CRO set up.
 
 
 <ul>
 <li>
 Strong background in synthetic organic chemistry, Interpretation of spectral data of compounds based on IR, NMR, HPLC, Mass, Elemental analysis and other analysis.
 </li>
 <li>
 Ability to independently search literature, design, optimize and develop synthetic processes for any given target molecules/APIs.
 </li>
 <li>
 Hands on experience in process development of diverse chemical class of APIs/ NCEs on lab scale.
 </li>
 <li>
 Excellent troubleshooting skills in synthesis and purification of target compounds.
 </li>
 <li>
 Should possess good verbal and written communication skills.
 </li>
 <li>
 Should possess good organizational, communication, and interpersonal skills.
 
 
 </li>
 </ul>
 
 Additional Desired Preferences
 
 
 
 <ul>
 <li>
 Extensive knowledge on wide range of organic reactions, and hands on experience in handling various sensitive chemicals/reagents.
 </li>
 <li>
 Track record of patents/ publications in synthetic organic chemistry/ process development.
 </li>
 <li>
 Should have exposure to GMP/GLP environment and documentation procedures. Have good practical, documentation &amp; presentation skills.
 </li>
 <li>
 Attention to detail, stratregic thinking and problem-solving skills.
 </li>
 <li>
 Demonstrated ability to work both independently and as a member of a team with a passion for quality
 
 
 </li>
 </ul>
 Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
 
 
 
 Job Category
 
 Contingent Staff
 
 
 
 Job Type
 
 Full-Time
</div>

Scientist III/Scientist IV, Synthetics (Contract)

Dr. Reddy's Laboratories

<div>
 
 Dr. Reddy&rsquo;s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because
 
 Good Health Can&rsquo;t Wait
 
 .
 
 
 
 
 We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.
 
 
 
 
 For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity &ndash; to strengthen our core further (the next steps) and to build the future (the new bets).
 
 
 
 
 &lsquo;The Next and the New&rsquo; is how we aim to continue to be the partner of choice &ndash; purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose &ndash; helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
 
 
 
 
 Dr Reddy&rsquo;s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ &amp; nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.
 
 
 
 
 
 
 Job Description
 
 
 
 
 
 Job Summary
 
 
 
 We are seeking a dynamic and experienced Formulation Scientist in Injectable division for designing and development of formulation process, ensuring quality by design (QbD) implementation, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer.
 
 
 
 
 
 Roles &amp; Responsibilities
 
 
 
 
 <ul>
 <li>
 You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval.
 </li>
 <li>
 You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections.
 </li>
 <li>
 You will be responsible to support in scale-up to pilot/plant scales for Injectable Products.
 </li>
 <li>
 You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions.
 </li>
 <li>
 You will be responsible for technology transfer and execution of the batches.
 </li>
 <li>
 You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up).
 </li>
 <li>
 You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development.
 </li>
 <li>
 You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 
 Educational qualification:
 
 Masters in Pharmaceutical/M.Tech in Chemical Engineering
 
 
 
 
 
 Minimum work experience:
 
 5 to 8 years of experience in pharmaceutical company in Injectable products.
 
 
 
 
 
 Skills &amp; attributes:
 
 
 
 
 Technical Skills
 
 
 
 
 <ul>
 <li>
 Have work experience on Formulation Development and expertise in inhalation/injectable dosage form.
 </li>
 <li>
 Experience in areas of product development for Generic Injectable
 </li>
 <li>
 Experience in Quality by Design (QbD).
 </li>
 <li>
 Experience in Process Optimization and scale up.
 </li>
 <li>
 Experience in Operational Excellence.
 </li>
 <li>
 Knowledge on Good Manufacturing Practice and Good Laboratory Practice.
 </li>
 <li>
 Experience in Technology Transfer.
 </li>
 </ul>
 
 
 Behavioral
 
 
 Skills
 
 
 
 
 <ul>
 <li>
 Excellent communication and interpersonal skills.
 </li>
 <li>
 Strong analytical and problem-solving abilities.
 </li>
 <li>
 Ability to work collaboratively with own team and cross-functional teams.
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 
 
 About the Department
 
 
 
 
 
 
 Integrated Product Development Organisation
 
 
 
 
 
 We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) &amp; Other dosages
 
 
 Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&amp;D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.
 
 
 
 
 
 Benefits Offered
 
 
 
 At Dr. Reddy&rsquo;s we actively help to catalyse your career growth and professional development through personalised learning programs.
 
 
 The benefits you will enjoy at Dr. Reddy&rsquo;s are on par with the best industry standards. They include, among other things and other essential equipment, joining &amp; relocation support, family support (Maternity &amp; Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
 
 
 
 
 
 Our Work Culture
 
 
 
 Ask any employee at Dr. Reddy&rsquo;s why they come to work every day and they&rsquo;ll say, because Good Health Can&rsquo;t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we&rsquo;re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
 
 
 For more details, please visit our career website at
 
 https://careers.drreddys.com/#!/
 
 
</div>

Formulation Scientist

<div>
 
 Description
 
 
 
 At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.
 
 
 USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds&mdash;regardless of background&mdash;to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.
 
 
 
 Brief Job Overview
 
 
 
 This is a non-supervisory position to support process development and scale-up of Active Pharmaceutical Ingredient (API) and related materials. The successful applicant in this role will work on projects including Analytical Method Development and evaluation for in-process samples for synthetic chemistry. The successful candidate will also perform a variety of non-routine and routine analytical tests, maintains safety &amp; GLP environment in the lab including development/validation of methods, stability studies and research projects in analytical chemistry. The successful applicant will direct, troubleshoot, and share insights on complex projects while drawing independent conclusions about the results and determining how to proceed with the project. They closely collaborate with other scientists and/or other USP personnel.
 
 
 
 How will YOU create impact here at USP?
 
 
 
 As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.
 
 
 Additionally, USP&rsquo;s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.
 
 
 
 The Scientist IV Has The Following Responsibilities
 
 
 
 <ul>
 <li>
 Support reaction monitoring, scale-up and final analysis of samples as per monograph /in-house procedures including method development/validation if required. Prepare development reports for Synthetic Support projects. Execute projects per the approved test protocols if assigned.
 </li>
 <li>
 In collaboration with the synthetics team evaluate, implement and grow Process Analytical Technologies (PAT) capabilities and expertise. This includes evaluation of process monitoring, understanding, and control via in line, online and at line techniques. Serve as technical expert and champion for PAT and/or process model building.
 </li>
 <li>
 Plan, execute, and complete the projects as per specifications, timelines, and budget.
 </li>
 <li>
 Responsible for preparation and review of SOPs, protocols, reports, etc.
 </li>
 <li>
 Ensure project requirements by coordinating with external vendors and all internal relevant departments.
 </li>
 <li>
 Responsible for ensuring the required maintenance and calibrations of the equipment
 </li>
 <li>
 Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments as assigned
 </li>
 <li>
 Preparation and planning for ISO-9001 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.
 </li>
 <li>
 Maintain GLP &amp; implement safety procedures while working in Lab.
 </li>
 <li>
 Work on any other assigned tasks/ lab management activities.
 </li>
 <li>
 Conversant with lab safety norms and strictly follow them.
 </li>
 <li>
 Collaborate within the team and cross functional teams
 </li>
 <li>
 Learn and practice Diversity, Equity, Inclusion &amp; Belonging culture
 
 
 </li>
 </ul>
 
 Who is USP Looking For?
 
 
 
 The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
 
 
 The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
 
 
 <ul>
 <li>
 MSc. in Analytical Chemistry / Organic Chemistry/M. Pharm, having 8-10 years of experience in Analytical Research and Development or Ph.D. with 4-7 years of experience in Analytical Research and Development.
 </li>
 <li>
 Must have hands on experience in working with chemical methods and handling instruments like HPLC, GC, LC-MS, GC-MS, FTIR, UV-Visible, wet chemistry, etc.
 </li>
 <li>
 Understanding of process analytical technology, chemometrics, and knowledge of in-line, online, at line process analytical tools (e.g., IR, Raman, HPLC)
 </li>
 <li>
 Experience in analytical testing and development with focus on process analytical chemistry and to understand, monitor and control chemical processes/reactions.
 </li>
 <li>
 A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry.
 </li>
 <li>
 Ability to perform analytical method developments and method validations as and when required.
 </li>
 <li>
 Excellent technical writing and verbal communication skills
 </li>
 <li>
 Good interpersonal skills and proven ability to function in a team-oriented environment are necessary.
 
 
 </li>
 </ul>
 We especially welcome applications from those who hold historically marginalized and/or underrepresented identities. This job description provides a portrait of an ideal candidate. Candidates who possess many, though perhaps not all, qualifications are encouraged to apply.
 
 
 
 Additional Desired Preferences
 
 
 
 <ul>
 <li>
 Hands on experience with PAT instruments, techniques, and models such as in line, at line, or online IR, Raman, HPLC, NMR, etc.
 </li>
 <li>
 Experience with a wide variety of software and laboratory information systems, including chemometric modeling software
 </li>
 <li>
 Working knowledge of API manufacturing and product testing (e.g. ICH guidelines, USP general chapters and monographs)
 </li>
 <li>
 Expertise with USP compendial methods and requirements (e.g. monographs and general chapter) and ICH quality guidelines
 </li>
 <li>
 Pharmaceutical laboratory experience, method development and method implementation in manufacturing environments, and/or continuous manufacturing experience.
 </li>
 <li>
 Strong project management skills with ability to be effective both independently and in collaborative teams
 </li>
 <li>
 Skilled in evaluation and interpretation of data; Ability to multi-task.
 </li>
 <li>
 Skilled in anticipating, troubleshooting, and solving technical problems.
 </li>
 <li>
 Takes personal responsibility to ensure work is delivered on time and is of the highest quality.
 
 
 </li>
 </ul>
 
 Supervisory Responsibilities
 
 
 
 NA
 
 
 
 Benefits
 
 
 
 USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
 
 
 Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
 
 
 
 Job Category
 
 Chemistry &amp; Scientific Standards
 
 
 
 Job Type
 
 Full-Time
</div>

Scientist IV, Analytical Research & Development (Process Analytical Technology)

Eli Lilly and Company

<div>
 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.
 
 
 The Position Of Principal Technical Services Rep - APIEM Reports To The TSMS Director &ndash; Peptides API EM And Provides Technical Leadership And Expertise In Conjunction With API EM Contract Manufacturer Personnel In The Reliable Supply And Commercialization Of Medicines With Safety First And Quality Always By
 
 
 <ul>
 <li>
 Developing and sustaining process knowledge in order to ensure the execution of the appropriate product, process, and operational control strategy at the Contract Manufacturer (CM).
 </li>
 <li>
 Direct and Indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy.
 </li>
 <li>
 Participation with internal or CM resources in technical transfer, process validation, and process data monitoring.
 </li>
 <li>
 Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM&rsquo;s CMs.
 
 
 
 </li>
 </ul>
 
 Key Objectives/Deliverables
 
 
 
 The candidate will be responsible for process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers.
 
 
 The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.
 
 
 
 Build and Sustain Process Team Relationships
 
 
 
 <ul>
 <li>
 Utilize past experiences with unit operation control to provide insight and feedback to members of the Lilly / CM Joint Process Team (JPT).
 </li>
 <li>
 Employ excellent communication skills to manage internal and external relationships.
 </li>
 <li>
 Build and maintain relationships with development and central technical organizations.
 </li>
 <li>
 Operate with &lsquo;Team Lilly&rsquo; in mind - including coaching and mentoring of peers and other scientists.
 
 
 
 </li>
 </ul>
 
 Develop and Sustain Process Knowledge
 
 
 
 <ul>
 <li>
 Provide technical oversight and stewardship for peptide manufacturing processes.
 </li>
 <li>
 Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
 </li>
 <li>
 Enable the development and maintenance of process knowledge infrastructure such as validated process monitoring spreadsheets
 </li>
 <li>
 Review and track key process parameters (i.e. CPP&rsquo;s, rOPP&rsquo;s, IPC, etc.)
 
 
 
 </li>
 </ul>
 
 Provide Process Support
 
 
 
 <ul>
 <li>
 Leads resolution of technical issues including those related to control strategy and manufacturing.
 </li>
 <li>
 Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
 </li>
 <li>
 Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
 </li>
 <li>
 Identify systemic issues affecting production and reliable supply from CMs
 </li>
 <li>
 Lead or participate in root cause analysis and CAPA development
 
 
 
 </li>
 </ul>
 
 Process Optimization &amp; Continuous Improvement
 
 
 
 <ul>
 <li>
 Influence and implement the network technical agenda and drive continuous improvement.
 </li>
 <li>
 Maintaining peptide processes in a state of compliance with US and global regulations
 </li>
 <li>
 Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
 </li>
 <li>
 Support development and technical analysis for on-going continuous improvement activities.
 </li>
 <li>
 Review and identify cost reduction opportunities, as well as process capacities and bottlenecks.
 </li>
 <li>
 Assist in prioritization of opportunities with respect to overall business objectives.
 </li>
 <li>
 Perform and promote optimization of unit operation cycle time, loading, and yield performance.
 
 
 
 </li>
 </ul>
 
 Basic Requirements
 
 
 
 <ul>
 <li>
 Bachelor of Science in Chemistry or Biochemistry
 </li>
 <li>
 5+ years of demonstrated experience and proficiency with GMP pharmaceutical manufacturing and working knowledge of regulatory expectations.
 </li>
 <li>
 Demonstrated ability to function in a team environment as a technical leader and as a member of teams.
 </li>
 <li>
 Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
 
 
 
 </li>
 </ul>
 
 Additional Preferences
 
 
 
 <ul>
 <li>
 Successful application of root cause analysis and systematic problem solving
 </li>
 <li>
 Knowledge and experience with Regulatory requirements
 </li>
 <li>
 Knowledge of data management practices across manufacturing
 </li>
 <li>
 Enthusiasm for changes, team spirit and flexibility
 </li>
 <li>
 Ability to influence and communicate to diverse groups on business, or technical issues within the site and function
 </li>
 <li>
 Proficiency in delivering complex tasks and/or tasks that are cross-functional
 </li>
 <li>
 Demonstrated Project Management skills and ability to coordinate complex projects
 
 
 
 </li>
 </ul>
 
 Other Information
 
 
 
 <li>
 The normal schedule for this position is Monday-Friday, 8 hours/day. However, teleconferences may routinely occur outside of these hours due to the time zones of contract manufacturers. Some off-shift work (night/weekend) may be required to support 24/7 operations
 </li>
 <li>
 Tasks require entering manufacturing and laboratory areas and will require wearing appropriate PPE.
 </li>
 Some travel (&lt;25%) is required. International travel may be required to support process start-ups, troubleshooting, and commercial manufacturing.
 
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 
 #WeAreLilly
</div>

API EM TS/MS Mfg. Scientist – Peptides

Bristol Myers Squibb

<div>
 
 Working with Us
 
 
 
 Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
 
 
 Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
 
 
 
 Senior Manager, Clinical Scientist
 
 
 
 
 Job Title
 
 
 
 Senior Manager, Clinical Scientist
 
 
 
 Division
 
 
 
 R&amp;D / Global Drug Development
 
 
 
 Functional Area Description
 
 
 
 The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
 
 
 
 Position Summary / Objective
 
 
 
 <ul>
 <li>
 Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
 </li>
 <li>
 May serve as Clinical Trial Lead for one or more trials
 </li>
 <li>
 May lead or support trial level activities for one or more trials with the necessary supervision
 </li>
 <li>
 May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
 
 
 </li>
 </ul>
 
 Position Responsibilities
 
 
 
 <ul>
 <li>
 Collaborate and liaise with external partners (e.g., KOLs)
 </li>
 <li>
 Seek out and enact best practices with instruction
 </li>
 <li>
 Provide regular and timely updates to manager/management as requested
 </li>
 <li>
 Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
 </li>
 <li>
 Conduct literature review
 </li>
 <li>
 Submit clinical documents to TMF
 </li>
 <li>
 Develop site and CRA training materials and present these at SIVs and Investigator meetings
 </li>
 <li>
 Review clinical narratives
 </li>
 <li>
 Monitor clinical data for specific trends
 </li>
 <li>
 Develop Data Review Plan in collaboration with Data Management
 </li>
 <li>
 Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
 </li>
 <li>
 Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
 
 
 </li>
 </ul>
 
 Degree Requirements
 
 
 
 <ul>
 <li>
 Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). MD-Pharmacology preferred
 
 
 </li>
 </ul>
 
 Experience Requirements
 
 
 
 <ul>
 <li>
 Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
 </li>
 <li>
 Ability to understand assigned protocol(s) and their requirements
 </li>
 <li>
 Basic knowledge skills to support program-specific data review and trend identification
 </li>
 <li>
 Intermediate medical writing skills and medical terminology
 </li>
 <li>
 Basic planning/project management skills (develop short range plans that are realistic and effective)
 
 
 </li>
 </ul>
 
 Key Competency Requirements
 
 
 
 <ul>
 <li>
 Detail-oriented with commitment to quality
 </li>
 <li>
 Basic knowledge of disease area, compound, current clinical landscape
 </li>
 <li>
 Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
 </li>
 <li>
 Intermediate critical thinking and problem-solving skills
 </li>
 <li>
 Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
 </li>
 <li>
 Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
 
 
 </li>
 </ul>
 
 Travel Required
 
 
 
 Domestic and International travel may be required.
 
 
 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
 
 
 
 Uniquely Interesting Work, Life-changing Careers
 
 
 
 With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
 
 
 
 On-site Protocol
 
 
 
 
 Responsibilities
 
 
 
 BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
 
 
 Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
 
 
 BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
 
 
 BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
 
 
 BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
 
 
 If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
 
 
 Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
 
 
</div>

Senior manager, Clinical Scientist

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API EM TS/MS Mfg. Scientist – Peptides

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